Specializing In Small And Early-Stage Partners, Not Just Small Batches

By Jennifer Gray and Eric Graban, Singota

For small and/or earlier-stage pharmaceutical companies trying to advance a small-volume drug product through preclinical and clinical trials, the temptation to partner with large, well-known CDMOs for aseptic manufacturing can be alluring. Their reputation as service providers for large pharmaceutical companies, along with their ability to provide additional services (e.g., drug substance manufacturing), can make them attractive as a potential partner for early-stage companies.

However, these larger CDMOs primarily are interested in large, high-volume batches that generate enough revenue to meet their business goals. While they can serve smaller companies in need of small batch fills, such work is not their priority.

Still, many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements, so they do not think to seek out such a partner. Singota is uniquely equipped to handle this subset of clientele. Our business model centers around this type of work, whereas, for the big CDMO, it just doesn't make financial sense to jump through the hoops that would be required for them to prioritize such organizations’ needs, whether it is batch sizes of a few hundred vials filled on a line, in a GMP environment (versus being hand-filled), or agile scheduling that accommodates the unknowns of development.